COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

COOK, INC.

The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Cook And Cook Spectrum Central Venous Catheters.

Pre-market Notification Details

• Device ID: K081113
• 510k Number: K081113
• Device Name: COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: COOK, INC. 750 DANIELS WAY Bloomington, IN 47404
• Contact: Susanne Galin
• Correspondent: Susanne Galin; COOK, INC. 750 DANIELS WAY Bloomington, IN 47404
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2008-04-18
• Decision Date: 2008-07-30
• Summary: summary